About 10 days ago, I complained about an unpublicized Class I recall, which was described in FDA’s Weekly Enforcement Report dated February 8, 2012. The recall involved 114 tons of cut leaf “curly” spinach from Tiro Tres Farms, Eagle Pass, TX. The offending spinach was recalled by the manufacturer after the product was found to be contaminated with E. coli O157:H7.

I received some comments – and some flak – about my article, so I decided to see whether this was a one-time incident or whether there have been other Class I recalls about which we consumers were never informed. The following recalls were gleaned from FDA Weekly Enforcement Reports dated on or after November 2, 2011.

– Nicho Produce Co., Inc. (Edinburg, TX):A CUT ABOVE produce items. Thirty-three (33) different items, including shredded, cut, sliced, diced or cubed salad greens, vegetables and fruits, most of them packed in 5-lb bags. Products were recalled due to potential contamination with Listeria monocytogenes. This was an FDA-initiated Class I recall, announced by letters dated December 9th and 19th, 2011, and involved 9,829.5 “pieces” distributed in Texas.

River Ranch Fresh Foods LLC, (Salinas, CA):River Ranch and Hy-Vee bagged salads and coleslaw with Best if Used by date of 4 NOV 2011. Product was recalled after FDA found two environmental sub samples positive for Listeria monocytogenes. This was an FDA-initiated Class I recall that was subsequent to an earlier public recall of Farmers Market and Hy-Vee brands of bagged salads, also produced by River Ranch. This stealth recall involved 588 cases of bagged salads, which were distributed to Indiana, Iowa and Canada.

Rio Queen Citrus, Inc. (Mission, TX):TexRio Tomatoes, packed in 20-lb bulk boxes, imported from Mexico. Notification of the company-initiated Class I recall was by telephone on November 25, 2011. Two hundred forty-three (243) boxes were recalled because the tomatoes were potentially contaminated with Salmonella. Distributed to Texas and Missouri.

Four Seasons Produce, Inc. (Ephrata, PA): Farm Wey labeled cantaloupes, Lot #32773301 & 32773302, manufactured by Farm-Wey Produce, Inc. (Lakeland, FL). Four Seasons recalled 1,064 cases (15/case) on November 19th by email, telephone and fax after being informed by New York State that the melons were potentially contaminated with Salmonella. The recalled cantaloupes were distributed to New York, Pennsylvania, Puerto Rico and Bermuda.

Combs Produce, LP (Dallas, TX):Natures Harvest Grape Tomatoes, recalled by email on November 25, 2011 due to potential contamination with Salmonella. Approximately 400 cases were distributed to Oklahoma and Texas.

These are just a few examples from less than 4 months’ worth of FDA Enforcement Reports. For brevity and simplicity, I limited myself to Class I microbiological hazards, and did not include undeclared allergens, foreign material contamination (i.e., metal, glass, etc) or undeclared/unapproved additives.

Prevor theorized that the E. coli O157:H7-contaminated spinach was not destined for direct retail sale; therefore, he concluded, there was “…no need to notify consumers.”

But, USDA’s Food Safety and Inspection Service routinely publicizes recalls of products that are destined strictly for the institutional market. Why should FDA not do likewise?

Prevor also suggests that the recall was not publicized to avoid worrying or confusing consumers, who would not differentiate between the recalled (curly) spinach from Texas and the unaffected (flat leaf) baby spinach from California and Arizona. He concludes that avoiding a public announcement was the responsible path, to prevent crushing “countless farmers and processors”.

Sorry, Jim, but how does that justification extrapolate to the “Branded” products I’ve cited above – especially those that were sold in retail-sized packaging bearing lot number identification and/or expiration dates?

Finally, Prevor ends his article with the following statement:

One suspects that the decision to not announce recalls when the announcement would not enhance public health is motivated by the desire to protect another value: Maintaining viable farms, industries, jobs, etc.

Interesting. I always thought that the primary responsibility of FDA was to protect public health.

FDA relies on consumers and consumer advocates to help it carry out its broad mandate. The agency has no choice – it cannot afford to inspect more than a tiny fraction of food producers and processors in the USA. But, like it or not, the flip side of this dependency is the need to keep consumers informed. Naive consumers, or those who are ignorant of existing recalls, are more likely to become casualties than collaborators.

When President Obama took office, he promised “transparency” in his administration. I grant that the workings of FDA, USDA and other US agencies are more open than those in many – perhaps most – other countries. Nevertheless, the President’s promise raised the bar for FDA. At the very least, there should be a consistent – and transparent – policy guiding the agency’s decisions on when and how to release information about recalls. This is especially true for FDA-initiated recalls.

Speaking as a consumer, and as a food safety microbiologist with more than 30 years of experience – several of them with Canada’s food safety regulatory agency – I strongly believe that all Class I recalls should be posted promptly on the government’s food safety website.

The recall process is detailed in the FDA Reguatory Procedures Manual, Chapter 7. The author of this article should review this chapter for an understanding of the recall procedures concerning firm-initated and fda-requested recalls.

jon

Don,
what is the difference between a firm-initiated and fda-requested recall? maybe you could include a link to chapter 7. and how is that relevant to the goal of transparency that Phyllis Entis writes about?